Trial Outcomes & Findings for A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols (NCT NCT00800735)
NCT ID: NCT00800735
Last Updated: 2013-10-30
Results Overview
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Baseline through 24 weeks after the end of treatment (up to 72 weeks)
Results posted on
2013-10-30
Participant Flow
Participant milestones
| Measure |
Pegylated-interferon Alfa-2a Plus Ribavirin
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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14
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Reasons for withdrawal
| Measure |
Pegylated-interferon Alfa-2a Plus Ribavirin
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
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|---|---|
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Overall Study
Administrative/Other
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2
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Overall Study
Insufficient Therapeutic Response
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2
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Overall Study
Violation of Selection Criteria at Entry
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7
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Overall Study
Withdrew Consent
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3
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Baseline Characteristics
A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
Baseline characteristics by cohort
| Measure |
Pegylated-interferon Alfa-2a Plus Ribavirin
n=30 Participants
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
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|---|---|
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Age Continuous
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48.5 years
STANDARD_DEVIATION 9.35 • n=5 Participants
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Sex: Female, Male
Female
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18 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black
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2 participants
n=5 Participants
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Race/Ethnicity, Customized
Caucasian
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28 participants
n=5 Participants
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Height
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170.0 cm
STANDARD_DEVIATION 7.28 • n=5 Participants
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Weight
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76.97 kg
STANDARD_DEVIATION 16.146 • n=5 Participants
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Body Mass Index (BMI)
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26.5 kg/m^2
STANDARD_DEVIATION 4.53 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline through 24 weeks after the end of treatment (up to 72 weeks)Population: All enrolled patients.
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Pegylated-interferon Alfa-2a Plus Ribavirin
n=30 Participants
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
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|---|---|
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Percentage of Participants Who Experienced at Least 1 Adverse Event.
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80.0 Percentage of participants
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Adverse Events
Pegylated-interferon Alfa-2a Plus Ribavirin
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegylated-interferon Alfa-2a Plus Ribavirin
n=30 participants at risk
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
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|---|---|
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Eye disorders
Retinal haemorrhage
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Infections and infestations
Conjunctivitis viral
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Infections and infestations
Laryngitis
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Infections and infestations
Sinusitis
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Injury, poisoning and procedural complications
Arthropod bite
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Injury, poisoning and procedural complications
Rib fracture
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Investigations
Prothrombin time prolonged
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Respiratory, thoracic and mediastinal disorders
Haemoptysis
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3.3%
1/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Other adverse events
| Measure |
Pegylated-interferon Alfa-2a Plus Ribavirin
n=30 participants at risk
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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13.3%
4/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Blood and lymphatic system disorders
Lymphopenia
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13.3%
4/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Endocrine disorders
Hyperthyroidism
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6.7%
2/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Gastrointestinal disorders
Dyspepsia
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10.0%
3/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Gastrointestinal disorders
Nausea
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26.7%
8/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Gastrointestinal disorders
Vomiting
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10.0%
3/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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General disorders
Asthenia
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16.7%
5/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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General disorders
Chills
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23.3%
7/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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General disorders
Fatigue
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53.3%
16/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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General disorders
Influenza like illness
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16.7%
5/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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General disorders
Pyrexia
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13.3%
4/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Infections and infestations
Bronchitis
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13.3%
4/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Infections and infestations
Sinusitis
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6.7%
2/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Infections and infestations
Urinary tract infection
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6.7%
2/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Metabolism and nutrition disorders
Decreased appetite
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10.0%
3/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Musculoskeletal and connective tissue disorders
Arthralgia
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13.3%
4/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Musculoskeletal and connective tissue disorders
Back pain
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6.7%
2/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Musculoskeletal and connective tissue disorders
Myalgia
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13.3%
4/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Nervous system disorders
Dizziness
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6.7%
2/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Nervous system disorders
Headache
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23.3%
7/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Psychiatric disorders
Depression
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16.7%
5/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Psychiatric disorders
Insomnia
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23.3%
7/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Respiratory, thoracic and mediastinal disorders
Cough
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13.3%
4/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
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10.0%
3/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Skin and subcutaneous tissue disorders
Alopecia
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16.7%
5/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Skin and subcutaneous tissue disorders
Dry skin
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16.7%
5/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Skin and subcutaneous tissue disorders
Pruritus
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30.0%
9/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Skin and subcutaneous tissue disorders
Rash
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20.0%
6/30 • Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Safety population: All enrolled participants.
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Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER